Green light for drugmaker Regeneron came after REGEN-COV2 was shown to reduce COVID-19 hospitalizations or emergency room visits for patients with underlying conditions
A sign for the Food And Drug Administration is seen outside the headquarters in White Oak, Maryland. AFP
Washington: A COVID-19[female[feminine The antibody treatment used to treat President Donald Trump was approved by the U.S. drug regulator on Saturday for people who have not yet been hospitalized with the disease but are at high risk.
The green light from drugmaker Regeneron came after REGEN-COV2, a combination of two lab-made antibodies, reduced COVID-19[female[feminine hospitalizations or emergency room visits related to patients with underlying conditions.
“Authorizing these monoclonal antibody therapies can help ambulatory patients avoid hospitalization and ease the burden on our health care system,” said Stephen Hahn, Commissioner of the Food and Drug Administration (FDA).
Leonard Schleifer, President and CEO of Regeneron, added that the move was “an important step in the fight against COVID-19[female[feminine , because high-risk patients in the United States will have access to a promising therapy early in their infection. “
Regeneron’s antibody therapy is the second synthetic antibody therapy to receive emergency use authorization (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted status on November 9.
The human immune system naturally develops anti-infective proteins called antibodies – but not everyone gets an adequate response, companies like Regeneron and Lilly have made laboratory solutions.
They work by binding to a surface protein of the SARS-CoV-2 virus and preventing it from invading human cells.
The FDA said the data supporting Regeneron’s EUA came from a clinical trial in 799 outpatients with mild to moderate symptoms of COVID-19[female[feminine .
For patients who were at high risk due to a variety of underlying conditions – from obesity to old age to diabetes – hospitalization and emergency room visits occurred in 3% of patients with received intravenous treatment.
This compared to nine percent in patients treated with placebo.
Patients treated with the drug also had lower remaining virus levels than placebo.
The company said it expects to have doses ready for 80,000 patients by the end of November and for about 300,000 total patients by the end of January 2021.
These will be made available to US patients at no additional cost as part of a US government program.
But with cases soaring in the United States and around the world, that means access will not be widespread. The United States added more than 360,000 new COVID-19[female[feminine cases in the last two days only.
The recommended dose is 1,200 milligrams of each of the two antibodies, for a total of 2,400 milligrams, as a single infusion.
Regeneron has received more than $ 450 million from the U.S. government for its COVID-19[female[feminine drug development efforts as part of Operation Warp Speed.
So-called monoclonal antibodies are a relatively new class of drugs considered to be very promising.
Last month, a drug-antibody Regeneron developed against Ebola received full FDA approval, the next step after EUA.
In the case of COVID-19[female[feminine Regeneron first found two highly effective antibodies against the SARS-CoV-2 virus, one from a mouse whose immune system was altered to resemble that of a human, the other from a human.
They then harvested the immune cells that made these antibodies and cultured them in a lab, to create a mass cure.
COVID-19[female[feminine vaccines, like those developed by Pfizer and Moderna, work by causing the immune system to make its own antibodies so that they are prepared when they encounter the virus.